NCT06916845

Data Collection for CV-3E AI Software Development

Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Capso Vision, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol. Participants will * adhere to bowel prep instructions and dietary requirements * ingest pro-kinetic medication and CapsoCam® Colon (CV-3E) * adhere to booster regimen and dietary requirements until capsule passes * retrieve capsule with retrieval kit per instructions and mail back to sponsor * participate in follow-up phone call

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	Colon Capsule	All participants will swallow the CapsoCam® Colon (CV-3E) for this study.

Timeline

• Start date: 2025-03-16
• Primary completion: 2025-06-06
• Completion: 2025-06-06
• First posted: 2025-04-08
• Last updated: 2025-07-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study